Joint MHRA/DIA Excellence in Pharmacovigilance

This course is designed to provide a firm grounding in key aspects of European Clinical Pre- and Post-Marketing Safety regulatory requirements.

TOPIC 5: RISK MANAGEMENT. SESSION 1: Risk Communication in EU – Challenges and Possibilities

Session Chair(s)

Gaby L. Danan, MD, PhD

Gaby L. Danan, MD, PhD

  • Pharmacovigilance Expert
  • GLD, France
Phil  Tregunno

Phil Tregunno

  • Head of Vigilance Operations, Safety & Surveillance
  • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
In accordance with the GVP Module V on Risk Management System, risk management plans (RMPs) should be submitted by companies to propose activities aiming to identify, characterise or minimise risks associated with medicinal products. Given the potential public health implications and costs of such interventions, RMPs should be based on robust epidemiological methods that will be described and examples discussed in this session. This session aims also to provide the background for understanding drug-related risks, and to present recent developments regarding risk communication.


Jan  Petracek, MD, MSc

Risk Communication in EU – Challenges and Possibilities

Jan Petracek, MD, MSc

  • Director
  • Institute of Pharmacovigilance, Czech Republic

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